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Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

NCT ID: NCT00556257

Last Updated: 2008-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

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A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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Immunosuppression, JAK3 inhibitor, kidney transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Arm 1

Treatment Arm 1 will also receive standard of care medications.

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Standard of care

Treatment Arm 2

Treatment Arm 2 will also receive select standard of care medications.

Group Type EXPERIMENTAL

CP-690-,550

Intervention Type DRUG

CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12

Interventions

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Cyclosporine

Standard of care

Intervention Type DRUG

CP-690-,550

CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recipient of first time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria

* Recipient of any non-kidney transplant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921037&StudyName=Study%20Of%20JAK3%20Inhibitor%20For%20The%20Prevention%20Of%20Acute%20Rejection%20In%20Kidney%20Transplant%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921037

Identifier Type: -

Identifier Source: org_study_id